AI-Assisted Mindfulness Intervention in Emotional Distress

Artificial Intelligence-Assisted Internet-Based Mindfulness Intervention for Emotional Distress: Protocol for a Randomized Controlled Trial on Long-Term Outcomes and Cost-Effectiveness

The goal of this clinical trial is to learn whether an artificial intelligence-assisted internet-based mindfulness intervention for emotional distress (iMIED) can prevent or reduce anxiety and depressive symptoms in adults with subclinical emotional distress. The main questions it aims to answer are:

Can iMIED reduce anxiety symptoms, as measured by the Generalized Anxiety Disorder-7 (GAD-7)? Can iMIED reduce depressive symptoms, as measured by the Patient Health Questionnaire-9 (PHQ-9)?

Researchers will compare participants receiving iMIED plus access to usual mental health resources with participants receiving usual mental health resources alone to see whether iMIED leads to greater improvement in emotional distress over time.

Participants will:

complete online screening and baseline assessments; be randomly assigned to either the iMIED intervention group or the control group; if assigned to the intervention group, complete a 49-day AI-assisted online mindfulness self-help program using a WeChat mini-program and AI support tool; complete follow-up online questionnaires during the intervention and at 3, 6, 12, 18, and 24 months after the intervention; report information on mental health symptoms, quality of life, healthcare use, sleep, stress, resilience, and life satisfaction.

Study Overview

• Status: Not yet recruiting
• Conditions: Subclinical Anxious Adults; Subclinical Depression; Subclinical Emotional Distress
• Intervention / Treatment: Combination product: Artificial Intelligence-Assisted Internet-Based Mindfulness Intervention

• Study Type: Interventional
• Enrollment (Estimated): 550
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yinan Zhang, PHD Candidate; Phone Number: 8615823339524; Email: yinanzhang25@stu.pku.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100871
      • Peking University
      • Contact: Yinan Zhang, PHD Candidate; Phone Number: 8615823339524; Email: yinanzhang25@stu.pku.edu.cn
      • Contact: Xinghua Liu, PHD; Phone Number: 8613371669818; Email: xinghua_liu@pku.edu.cnxinghua_liu@pku.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Aged 18 to 65 years PHQ-9 or GAD-7 score ≥5 Able to use a smartphone or other internet-enabled electronic device and possessing sufficient digital literacy to participate in the online intervention and complete follow-up assessments Willing to participate and able to provide informed consent

Exclusion Criteria:

Current psychotic disorder or bipolar disorder Current organic mental disorder, pervasive developmental disorder, severe cognitive impairment, or substance use disorder Current suicide risk, defined as a score of ≥2 on Item 9 of the PHQ-9 Previous participation in a structured 8-week mindfulness course or the 49-day self-guided course developed by the Peking University Mindfulness Laboratory

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: WL
Experimental: iMIED	Combination product: Artificial Intelligence-Assisted Internet-Based Mindfulness Intervention; Delivered via the internet, the intervention is grounded in the Psychopathology Diamond Model proposed by Liu Xinghua's team. It integrates four core strategies: increasing engagement in life, enhancing distress tolerance, reducing excessive emotional behavior, and improving cognitive flexibility (Liu, 2024). Based on advanced large language models, including Tencent Hunyuan and DeepSeek R1, and supported by an official MIED knowledge base comprising the "Mindfulness Practice" WeChat public account, supervision Q&A records, and other official materials produced by Liu Xinghua and colleagues, the team developed an AI assistant called the "MIED Mindfulness Assistant," along with a WeChat self-help mini-program. Together, these tools support participants' learning and practice over a 49-day continuous training period (Liu, 2024).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized Anxiety Disorder-7 (GAD-7)	The GAD-7 is a 7-item self-report questionnaire used to assess the severity of anxiety symptoms over the past 2 weeks. Each item is rated on a 4-point scale from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 21. Higher scores indicate greater anxiety severity. The GAD-7 has demonstrated good reliability and validity in both clinical and general populations (Spitzer et al., 2006).	Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 is a 9-item self-report questionnaire used to assess the severity of depressive symptoms over the past 2 weeks. Each item is rated on a 4-point scale from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 27. Higher scores indicate greater depression severity. The PHQ-9 has demonstrated good reliability and validity in both clinical and general populations (Kroenke et al., 2001).	Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Inventory of Costs in Patients with Psychiatric Disorders (TIC-P)	TIC-P is a widely used health economic instrument in mental health research for assessing psychiatric healthcare use and societal costs, including service utilization, medication use, and productivity losses (Bouwmans et al., 2013). In this study, TIC-P will be used to record healthcare resource consumption during the trial, including outpatient visits, medication costs, and other healthcare-related expenditures. To capture healthcare utilization more comprehensively, a self-developed healthcare utilization questionnaire will also be administered.	Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
EuroQol 5-Dimension 5-Level (EQ-5D-5L)	This is one of the most widely used instruments in health economic evaluation for measuring health-related quality of life and includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five response levels (Devlin & Brooks, 2017; Herdman et al., 2011). The health utility values derived from EQ-5D-5L will be used to calculate Quality-Adjusted Life Years (QALYs) for cost-utility analysis (Drummond et al., 2015; Group, 1990).	Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Connor-Davidson Resilience Scale (CD-RISC)	Resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC), one of the most widely used instruments for assessing the ability to cope with stress and adversity, with good reliability and validity (Connor & Davidson, 2003).	Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Perceived Stress Scale (PSS)	Perceived stress will be measured using the Perceived Stress Scale (PSS), a widely used instrument that assesses individuals' subjective appraisal of stress over a recent period (Cohen et al., 1983).	Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Satisfaction With Life Scale (SWLS)	Life satisfaction will be measured using the Satisfaction With Life Scale (SWLS), which assesses individuals' cognitive evaluation of their overall life circumstances and has sound psychometric properties (Diener et al., 1985).	Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Insomnia Severity Index (ISI)	Sleep status will be assessed using the Insomnia Severity Index (ISI), a brief 7-item self-report scale widely used in clinical and digital health research to assess the severity of insomnia symptoms and their impact on daily functioning (Bastien et al., 2001; Morin et al., 2011).	Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
Overall Anxiety Severity and Impairment Scale (OASIS)	The OASIS is a 5-item self-report measure designed to assess the frequency and severity of anxiety symptoms, as well as the extent of anxiety-related functional impairment and avoidance, over the past week. Each item is rated on a 5-point scale from 0 to 4, with total scores ranging from 0 to 20. Higher scores indicate greater overall anxiety severity and impairment. The OASIS has demonstrated good reliability and validity in both clinical and nonclinical samples (Norman et al., 2006).	Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
Overall Depression Severity and Impairment Scale (ODSIS)	The ODSIS is a 5-item self-report measure designed to assess the frequency and severity of depressive symptoms, as well as depression-related functional impairment and avoidance, over the past week. Each item is rated on a 5-point scale from 0 to 4, with total scores ranging from 0 to 20. Higher scores indicate greater overall depression severity and impairment. The ODSIS has demonstrated good reliability and validity in both clinical and nonclinical samples (Bentley et al., 2014).	Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Five Facet Mindfulness Questionnaire (FFMQ)	Mindfulness will be assessed using the Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ measures trait mindfulness across five dimensions: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. It is one of the most widely used instruments in mindfulness research and has demonstrated good reliability and validity (Baer et al., 2006). In this study, the total FFMQ score and its subscale scores will be analyzed as exploratory continuous variables	Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Engaging in Life Scale	The Engaging in Life Scale will be used to assess the degree to which individuals engage in key life domains such as work, study, social interaction, and sleep, and is an important tool for evaluating levels of engagement in life (Chen et al., 2026).	Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Distress Tolerance Scale (DTS)	Distress tolerance will be assessed using the Distress Tolerance Scale (DTS), which measures individuals' capacity to tolerate negative emotional experiences and their regulatory responses to emotional distress (Simons & Gaher, 2005).	Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Discomfort Intolerance Scale (DIS)	The Discomfort Intolerance Scale (DIS) will be used to assess tolerance of unpleasant bodily sensations, which has been widely applied in anxiety disorder and emotion regulation research (Schmidt et al., 2006).	Time Frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Excessive Emotional Behavior Scale (EEBS)	The Excessive Emotional Behavior Scale (EEBS) will be used to assess excessive emotion-driven and avoidant behaviors under negative affective states, thereby providing a more comprehensive assessment of this psychological process (Zhang et al., 2026).	Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Brief Experiential Avoidance Questionnaire (BEAQ)	The Brief Experiential Avoidance Questionnaire (BEAQ) will be used to further assess experiential avoidance as a core process (Gámez et al., 2014).	Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Cognitive Flexibility Inventory (CFI)	Cognitive flexibility will be measured using the Cognitive Flexibility Inventory (CFI), which assesses individuals' ability to shift cognitive frameworks, generate alternative explanations, and adopt adaptive thinking strategies under stress (Dennis & Vander Wal, 2010).	Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
AI interaction indicators	To evaluate the role of AI support in the intervention, the following behavioral data will be recorded: number of interactions with the AI assistant, number of personalized feedback responses, and daily duration of use. Associations between these variables and intervention outcomes will then be analyzed.	immediately post-intervention at Week 8 (T3)
Feasibility and acceptability indicators	To assess the scalability of iMIED in real-world settings, the following indicators will be measured: intervention completion rate, average usage frequency, participant adherence (proportion of exercises completed), and user satisfaction.	immediately post-intervention at Week 8 (T3)
the Client Satisfaction Questionnaire (CSQ-8)	Satisfaction will be measured using the Client Satisfaction Questionnaire (CSQ-8), an 8-item instrument assessing participants' overall satisfaction with the intervention service (Attkisson & Zwick, 1982).	immediately post-intervention at Week 8 (T3)
Adverse Events	To evaluate the safety of the intervention, this study will record adverse events (AEs) and serious adverse events (SAEs) occurring during the study period. These events will be defined, documented, and reported in accordance with international clinical trial guidelines, and will be descriptively analyzed with respect to the time of occurrence, severity, relationship to the intervention, and outcomes, in order to comprehensively assess the safety and acceptability of iMIED (Guideline, 1994).	Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.

Collaborators and Investigators

• Sponsor: Xinghua Liu

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): April 15, 2029
• Study Completion (Estimated): May 15, 2029

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: emotional distress; artificial intelligence-assisted intervention; internet-based mindfulness intervention; subclinical anxiety and depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: E20260331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be made publicly available because the study involves sensitive mental health data and participant privacy must be protected. Requests for additional information regarding the study may be directed to the corresponding author.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No